Her 2 neu metflstatic breast cancer; low dose sequential docetaxel - capecitabine chemotherapy as first line treatment a clinical trial of cancer research group Pakistan

To evaluate the efficacy and toxicity of low dose sequential docetaxel-capecitabine chemotherapy as first line treatment of HER 2 negative metastatic breast cancer [MBC]. Experimental Study, Clinical Trial. Three different oncology centers, collaborating under the Cancer Research Group Pakistan. From June 2006 to December 2007. Female breast cancer patients with visceral or visceral and bone metastases and a KPS > 70 were eligible. Results: 38 patients were enrolled. Median age was 49 years [Range 32-70]. With docetaxel treatment, CR was seen in 06 [16%] patients and PR in 20 [53%] with an overall response rate of 69%. Stable disease was seen in 10 [26%] and PD in 02 [05%]. Four out of six complete responses were in patients with liver metastases. Thirty six patients received capecitabine. Thirty were evaluable for response. Capecitabine added one CR [3.33%] and six partial responses [20%]. Two patients [6.67%] who had a partial response to docetaxel relapsed during capecitabine treatment. As a result at the completion of the therapy CR was seen in 07 patients [18.42%], PR in 23 patients [60.53%] with SD and PD in, 4 patients [10.53%] each. An overall RR of 78.94% was seen. Median time to progression was 10.9 months [range, 3-22 months] and at a median follow up time of 24 months [range, 16 -34 months] 13 patients have died with an overall survival probability of docetaxel -capecitabine sequential therapy of 0.68. Significant docetaxel specific grade 3/4 toxicities included neutropenia and diarrhea in 14 [36.84%] and 03 [07.89%] respectively. Febrile neutropenia was seen in 06 [15.79%]. Capecitabine specific significant grade 3 toxicities included hand-foot syndrome in three patients [8.33%] and diarrhea in 2 [5.56%]. Stomatitis, dermatitis, fatigue was seen in one patient [2.78%] each. This treatment schedule of low dose sequential docetaxel - capecitabine is an effective first line treatment of HER 2 negative MBC that provides good overall response rate, manageable toxicity and improved survival

Single agent low dose capecitabine subsequent to docetaxel chemotherapy in HER-2 negative metastatic breast cancer

The objective of this study was to evaluate the efficacy and toxicity of low dose capecitabine chemotherapy in patients with metastatic breast cancer [MBC] who have previously received first line docetaxel chemotherapy. Metastatic breast cancer patients who responded or achieved a stable disease with first line docetaxel were enrolled. Female patients with visceral or visceral and bone metastases and a KPS > 70 were eligible. Adequate marrow, renal and hepatic function was required. Metastatic brain disease and bone as the only site of disease were excluded. Informed consent was obtained from all patients. Capecitabine 1,000 mg/m2 B.I.D 14 days for four cycles were given. Cycles were repeated every 3 weeks. Response Evaluation Criteria in Solid Tumors [RECIST] was used for evaluation of response and common Toxicity Criteria [CTC] Version 3.0 for evaluation of toxicity. From September 2006 to December 2007, 38 patients were enrolled. Median age was 49 years [Range 32-70]. Thirty six patients had received docetaxel at a dose of 75 mg/m2 for four cycles. Six patients had already achieved a complete response, 20 partial response and ten had achieved stable disease. Capecitabine added one CR [3.33%] and six partial responses [20%]. Median time to progression after capecitabine was 6.9 months [range, 3-22 months] and at a median follow up time of 24 months [range, 16 -34 months] 13 patients have died with an overall survival probability of docetaxel - capecitabine sequential therapy of 0.68. Significant grade 3 toxicities included hand-foot syndrome in three patients [8.33%], diarrhea in 2 [5.56%], stomatitis, dermatitis, fatigue and decrease in appetite in one patient [2.78%] each. Grade 2 toxicity included hand-foot syndrome in 12 [33.33%] patients, diarrhea and stomatitis in 8 patients [22.22%] each. Most common hematological toxicity included lymphopenia and anemia seen in 16 [44.44%] and 14 [38.89%] respectively. This treatment schedule of low dose capecitabine after docetaxel treatment is an effective treatment of MBC and has a manageable toxicity profile

Cisplatin nephrotoxicity and hydration protocols

To evaluate the nephrotoxicity of cisplatin in cancer patients, using different protocols of hydration. Randomized controlled trial. This study was conducted between 1st June to 30th November 2004. Ninety-nine patients with normal renal Junction were enrolled in the study and randomly assigned into the 3 study groups, each group having 33 patients. In group 1 hydration was done with saline [2 liter] alone, in group 2 with saline [2 liter] and furosemide [40mg] and in group 3 with saline [2 liter] and mannitol [100ml]. All 3 group patients were given cisplatin infusion 100 mg/m2 over 1 hour and the cycles repeated every 21-28 days. Twenty four hour creatinine clearance was measured before and after 6th day of the chemotherapy in all patients. For the first cycle of chemotherapy the 24-hour urinary creatinine clearance before chemotherapy for saline group was 95.54 +/- 15.27, for saline and furosemide group 98.43 +/- 13.44 and for saline and mannitol group 97.45 +/- 14.05 ml/min and after 6th day of cisplatin infusion was 77.4 +/- 14.59 for saline group, 86.06 +/- 11.9 for saline and furosemide group and 82.29 +/- 13.64 for saline and mannitol group. The reduction in creatinine clearance was less with saline and furosemide group [12.6%] as compared to saline and mannitol group [15.6%] and saline alone [18.9%] which is statistically significant. Each patient in these 3 study groups received many courses of cisplatin and showed the similar pattern. Hydration with saline and furosemide is less nephrotoxic than other protocols with cisplatin infusion